search
Back to results

Log2Lose: Incenting Weight Loss and Dietary Self-monitoring in Real-time to Improve Weight Management Among Adults With Obesity

Primary Purpose

Obesity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Incentives for dietary self-monitoring and weight loss
Incentives for dietary self-monitoring
Incentives for weight loss
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI ≥30 kg/m2
  • Desire to lose weight
  • Agrees to attend visits per protocol
  • Access to telephone
  • Transportation and ability to attend in-person study visits at 0, 6, 12 and 18 months
  • Able to stand for weight measurements without assistance
  • Able to speak and read English
  • Able to download and use the MyFitnessPal and Fitbit apps daily
  • Possess smart phone with data and texting plan
  • E-mail address
  • Reliable access to internet
  • Able to connect to a video conference call using a smartphone, tablet or computer with a webcam and microphone
  • Score of at least 4 out of 6 on a validated cognitive screener

Exclusion Criteria:

  • Weight >380 lb
  • Weight loss of at least 5 lbs in the month prior to screening
  • Currently enrolled or enrollment in previous month in a clinical, research, or community program focusing on lifestyle change that could affect weight
  • Current use of weight loss medication
  • History of bariatric surgery or planning to have bariatric surgery in the study timeframe
  • Residing in a nursing home or receiving home health care
  • Impaired hearing
  • Significant dementia, drug or alcohol misuse, or unstable psychiatric illness (e.g., schizophrenia, psychosis)
  • Current treatment for cancer or being treated for cancer (besides basal cell carcinoma or squamous cell) in the last 6 months
  • Use of insulin, sulfonylureas, or meglitinides due to increased risk for hypoglycemia
  • Pregnant, breastfeeding, or planning to become pregnant within the study timeframe
  • Diuretic medication doses higher than hydrochlorothiazide 25 mg daily, furosemide 40 mg daily, torsemide 20 mg daily, bumetanide 1 mg daily, or any use of metolazone; use of potassium-sparing diuretics is acceptable
  • Chronic kidney disease at stage 4 or 5
  • Unstable heart disease in the 6 months prior to screening
  • Exertional chest pain or dyspnea
  • History of ascites requiring paracentesis
  • Pain, fainting or other condition that prohibits mild/moderate exercise

Sites / Locations

  • Duke University Medical Center
  • University of Wisconsin-Madison

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Combined

Dietary self-monitoring

Weight loss

Control

Arm Description

Weekly incentives for dietary self-monitoring and weight loss

Weekly incentives for dietary self-monitoring

Weekly incentives for weight loss

Outcomes

Primary Outcome Measures

Percent of participants who achieve clinically significant weight loss of at least 5 percent of baseline weight at 26 weeks
Measured on a calibrated, digital scale to the nearest 0.1 kg

Secondary Outcome Measures

Percent of participants who achieve clinically significant weight loss of at least 5 percent of baseline weight at 52 weeks
Measured on a calibrated, digital scale to the nearest 0.1 kg
Percent of participants who achieve clinically significant weight loss of at least 5 percent of baseline weight at 78 weeks
Measured on a calibrated, digital scale to the nearest 0.1 kg
Change in dose equivalents of cardiovascular medications from baseline to 78 weeks
Dose equivalents for antihypertensive, antilipemic, and type 2 diabetes medications
Change in diastolic blood pressure from baseline to 26, 52, and 78 weeks
Average of two sequential measurements measured on a digital blood pressure monitor. A second reading will be taken one minute after the first. If the difference between the systolic measurements is greater than 15mmHg, then a third reading will be taken, one minute after the second reading.
Change in systolic blood pressure from baseline to 26, 52, and 78 weeks
Average of two sequential measurements measured on a digital blood pressure monitor. A second reading will be taken one minute after the first. If the difference between the systolic measurements is greater than 15mmHg, then a third reading will be taken, one minute after the second reading.

Full Information

First Posted
February 22, 2021
Last Updated
October 12, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
Duke University, National Heart, Lung, and Blood Institute (NHLBI)
search

1. Study Identification

Unique Protocol Identification Number
NCT04770909
Brief Title
Log2Lose: Incenting Weight Loss and Dietary Self-monitoring in Real-time to Improve Weight Management Among Adults With Obesity
Official Title
Log2Lose: Incenting Weight Loss and Dietary Self-monitoring in Real-time to Improve Weight Management Among Adults With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 13, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Duke University, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study involves an evaluation of whether providing small incentives weekly for dietary self-monitoring and/or weight loss improves short- and long-term weight loss. Participants can expect to be on study for 18 months.
Detailed Description
In this two-site, randomized, single-blinded, longitudinal 2x2 factorial study, called Log2Lose, adults with obesity from Madison, WI and Durham, NC will be offered a 78 week, evidence-based behavioral weight management program comprising an incentivized weight loss intervention for 26 weeks (Phase I), an incentivized weight loss maintenance intervention for 26 weeks (Phase II), and a non-incentivized weight maintenance intervention for 26 weeks (Phase III). Participants will be randomized in a 2x2 design to receive adjunctive incentives for either weekly weight loss or dietary self-monitoring, both, or neither. The investigators will assess the proportion of participants achieving clinically significant weight loss of greater than or equal to 5 percent at the end of each phase. All participants will participate in an 18-month weight management program delivered via videoconference.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
2 (incentives for dietary self-monitoring: yes vs. no) x 2 (incentives for weight loss: yes vs. no)
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
700 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combined
Arm Type
Experimental
Arm Description
Weekly incentives for dietary self-monitoring and weight loss
Arm Title
Dietary self-monitoring
Arm Type
Experimental
Arm Description
Weekly incentives for dietary self-monitoring
Arm Title
Weight loss
Arm Type
Experimental
Arm Description
Weekly incentives for weight loss
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Incentives for dietary self-monitoring and weight loss
Intervention Description
Participants can earn up to $300 during the trial for achieving adequate dietary self-monitoring and weight loss
Intervention Type
Behavioral
Intervention Name(s)
Incentives for dietary self-monitoring
Intervention Description
Participants can earn up to $300 during the trial for achieving adequate dietary self-monitoring
Intervention Type
Behavioral
Intervention Name(s)
Incentives for weight loss
Intervention Description
Participants can earn up to $300 during the trial for achieving weight loss
Primary Outcome Measure Information:
Title
Percent of participants who achieve clinically significant weight loss of at least 5 percent of baseline weight at 26 weeks
Description
Measured on a calibrated, digital scale to the nearest 0.1 kg
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Percent of participants who achieve clinically significant weight loss of at least 5 percent of baseline weight at 52 weeks
Description
Measured on a calibrated, digital scale to the nearest 0.1 kg
Time Frame
52 weeks
Title
Percent of participants who achieve clinically significant weight loss of at least 5 percent of baseline weight at 78 weeks
Description
Measured on a calibrated, digital scale to the nearest 0.1 kg
Time Frame
78 weeks
Title
Change in dose equivalents of cardiovascular medications from baseline to 78 weeks
Description
Dose equivalents for antihypertensive, antilipemic, and type 2 diabetes medications
Time Frame
Baseline, 78 weeks
Title
Change in diastolic blood pressure from baseline to 26, 52, and 78 weeks
Description
Average of two sequential measurements measured on a digital blood pressure monitor. A second reading will be taken one minute after the first. If the difference between the systolic measurements is greater than 15mmHg, then a third reading will be taken, one minute after the second reading.
Time Frame
Baseline, 26, 52, and 78 weeks
Title
Change in systolic blood pressure from baseline to 26, 52, and 78 weeks
Description
Average of two sequential measurements measured on a digital blood pressure monitor. A second reading will be taken one minute after the first. If the difference between the systolic measurements is greater than 15mmHg, then a third reading will be taken, one minute after the second reading.
Time Frame
Baseline, 26, 52, and 78 weeks
Other Pre-specified Outcome Measures:
Title
Intrinsic motivation for weight loss as assessed by modified Treatment Self-Regulation Questionnaire
Description
Association of intrinsic motivation for weight loss with proportion of patients who achieve clinically significant weight loss of at least 5 percent of baseline weight at 26 weeks will be measured with modified version of Treatment Self-Regulation Questionnaire. Intrinsic motivation will be calculated as mean of items 2, 4, 6, 8, 11, 14, 16, 17. Each item can be answered from '1 - not at all true' to '6 - very true'. Lower scores correspond to lower intrinsic motivation for weight loss
Time Frame
26 weeks
Title
Extrinsic motivation for weight loss as assessed by modified Treatment Self-Regulation Questionnaire
Description
Association of extrinsic motivation for weight loss with proportion of patients who achieve clinically significant weight loss of at least 5 percent of baseline weight at 26 weeks will be measured with modified version of Treatment Self-Regulation Questionnaire. Extrinsic motivation will be calculated as mean of items 1, 3, 5, 7, 9, 10, 12, 13, 15, 18. Each item can be answered from '1 - not at all true' to '6 - very true'. Lower scores correspond to lower extrinsic motivation for weight loss
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI ≥30 kg/m2 Desire to lose weight Agrees to attend visits per protocol Access to telephone Transportation and ability to attend in-person study visits at 0, 6, 12 and 18 months Able to stand for weight measurements without assistance Able to speak and read English Able to download and use the MyFitnessPal and Fitbit apps daily Possess smart phone with data and texting plan E-mail address Reliable access to internet Able to connect to a video conference call using a smartphone, tablet or computer with a webcam and microphone Score of at least 4 out of 6 on a validated cognitive screener Exclusion Criteria: Weight >380 lb Weight loss of at least 10 lbs in the month prior to screening Currently enrolled or enrollment in previous month in a clinical, research, or community program focusing on lifestyle change that could affect weight Current use of weight loss medication History of bariatric surgery or planning to have bariatric surgery in the study timeframe Residing in a nursing home or receiving home health care Impaired hearing Significant dementia, drug or alcohol misuse, or unstable psychiatric illness (e.g., schizophrenia, psychosis) Current treatment for cancer or being treated for cancer (besides basal cell carcinoma or squamous cell) in the last 6 months Use of insulin, sulfonylureas, or meglitinides due to increased risk for hypoglycemia Pregnant, breastfeeding, or planning to become pregnant within the study timeframe Diuretic medication doses higher than hydrochlorothiazide 25 mg daily, furosemide 40 mg daily, torsemide 20 mg daily, bumetanide 1 mg daily, or any use of metolazone; use of potassium-sparing diuretics is acceptable Chronic kidney disease at stage 4 or 5 Unstable heart disease in the 6 months prior to screening Exertional chest pain or dyspnea History of ascites requiring paracentesis Pain, fainting or other condition that prohibits mild/moderate exercise
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corrine I Voils, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
First, investigators will strip all data of personal identifiers (i.e., personal health information (PHI)) in accordance with the HIPAA privacy rule. Each consented and enrolled participant will be assigned a unique study ID, which will be the only participant-level identifier. Time information starting at baseline will be coded in units of study time, with baseline = '0' and termination of 18 months or dropout for all participants, regardless of the calendar date of their baseline visit. Proprietary software code will be shared in accordance with institutional policies and consent of the creators.
IPD Sharing Time Frame
Study data will be made available for use by investigators not associated with the proposed study within three years after the primary results have been published.
IPD Sharing Access Criteria
The data will be used for research or implementation purposes and not to identify individual participants The data must be secured using the appropriate computer technology The data must be destroyed or returned after analyses are complete The authors of any manuscript resulting from the Log2Lose data must acknowledge the source of the data upon which their manuscript is based. Any analyses for the purpose of presentation, abstracts, and/or publications must be coordinated with the Log2Lose leadership team, so there can be some coordination of analyses to ensure that redundant analyses are not being performed independently All coauthors must be given an opportunity for review and approval of a draft manuscript prior to submission for publication.

Learn more about this trial

Log2Lose: Incenting Weight Loss and Dietary Self-monitoring in Real-time to Improve Weight Management Among Adults With Obesity

We'll reach out to this number within 24 hrs